Multiple Zenith Alpha Thoracic Endovascular Graft Products 의 리콜

Recall

RC-2017-RN-00419-1

Class I

2017-03-29

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00419-1

The instructions for use (ifu) for the zenith alpha thoracic endovascular graft have been updated. these updates are of key importance when using the device to treat blunt thoracic aortic injury (btai), which is now covered under the newly approved indication for isolated lesions of the descending thoracic aorta. there have been five reports of graft thrombosis/occlusion during global commercial use of the device, each following treatment for btai. one case resulted in patient death, and three cases resulted in reintervention. patients already treated for btai should be followed in accordance with the current ifu, since follow-up has not been amended.

Cook Medical is requesting surgeons refer to the new version of the Instructions for Use (IFU) for the Zenith Alpha Thoracic Endovascular Graft in particular to the key updates regarding the use of the device to treat blunt thoracic aortic injury (BTAI), which is now covered under the newly approved indication for isolated lesions of the descending thoracic aorta. Surgeons are advised that patients already treated for BTAI should be followed in accordance with the current IFU, since follow-up has not been amended. (Please note that this recall is for information purposes. No devices need to be returned).